The pharmaceutical and biotech markets require a high level of functional consistency from filtration products. To provide a higher level of confidence for these customers, ErtelAlsop drafted its Drug Master File and submitted it to the FDA Center for Drug Evaluation and Research. ErtelAlsop manufactures all filter pads to very high standards, and the Drug Master File provides the documentation to ensure consistency in manufacturing and raw materials. All Pharmaceutical Grade Depth Filter Media and Filter Sheets manufactured by ErtelAlsop are fully lot traceable back to the raw material suppliers, and their suppliers, where applicable and are supplied with a “P” certificate. The low extractable content, low LAL concentrations, and highly consistent manufacturing process, make ErtelAlsop Pharmaceutical Grade Depth Filter Media and Filter Sheets the ideal choice for your critical application
- High purity
- USP Class VI tested
- Fully lot traceable
- Low endotoxin content
- Supported through Validation Guide
- Biotech and Pharmaceutical
- Fermentor(bioreactor) broth harvest
- Centrate clarification
- TFF permeate clarification
- HCP (Host Cell Protrein) removal
- Chromotograph column protection
- Aggregate removal
- DNA & Virus reduction
ErtelAlsop also offers a Validation Guide to assist in the validation of its filter pads in your process. The Validation Guide contains information regarding raw materials, extractables, and general information about the product. The combination of ErtelAlsop “P” grade filter pads and ErtelAlsop’s BioClean® plate and frame filter press design, can help to simplify your depth filtration validation now more than ever.